PKL PPC170

Coagulation Analyzer

Operation Manual
NOTE

1) Carefully read this manual before first operating the analyzer.

2) Inspect the electrical requirements of the analyzer before power on,
and properly connect the grounding wire.
3) Turn off the power to the analyzer and disconnect the power cord if the
analyzer is idle for a long time.
4) Do not run the analyzer if it’s in an abnormal or damaged condition.
5) There is potential biohazard of the reagents and samples; operator
should follow proper biosafety practices. Dispose of waste reagent and
sample in accordance with local, national regulations.
 Contents
Copyright and Declaration ................................................................................................ 1
Chapter 1 System Description ......................................................................................... 3
1.1 Overview ............................................................................................................ 3
1.2 Electrical Level................................................................................................... 3
1.3 Technical Specification ...................................................................................... 3
1.4 Principle ............................................................................................................. 6
1.5 Structure ............................................................................................................ 6
Chapter 2 Installation ........................................................................................................ 8
2.1 Package Inspection ........................................................................................... 8
2.2 Installation Requirements .................................................................................. 8
2.3 Printer Installation .............................................................................................. 8
2.4 Accessories Connection .................................................................................... 9
Chapter 3 Operation ........................................................................................................ 10
3.1 Power On ......................................................................................................... 10
3.2 Test Screen Description................................................................................... 10
3.3 Keyboard ......................................................................................................... 11
3.4 Main Menu ....................................................................................................... 12
3.4.1 Set......................................................................................................... 13
3.4.2 Time ...................................................................................................... 13
3.4.3 No. ........................................................................................................ 13
3.4.4 Query .................................................................................................... 13
3.4.4.1 Query Menu .......................................................................................... 13
3.4.4.2 Normal Test Data Query ....................................................................... 14
3.4.5 Calibration ............................................................................................. 15
3.4.6 Max Test Time ....................................................................................... 16
3.4.7 FIB Unit ................................................................................................. 16
3.4.8 Print and Default ................................................................................... 16
3.4.9 Technical Support ................................................................................. 17
3.5 Test Item .......................................................................................................... 17
3.5.1 Quality Control ...................................................................................... 17
3.5.2 PT Test .................................................................................................. 19
3.5.3 APTT Test ............................................................................................. 19
3.5.4 TT Test .................................................................................................. 19
3.5.5 FIB Test ................................................................................................. 20
3.5.6 Blood Coagulation Factor Test ............................................................. 20
3.5.7 Result Report ........................................................................................ 21
3.5.8 Concentration Curve Calibration .......................................................... 21
3.5.9 Sample Collection and Storage ............................................................ 21
3.5.10 Sample Mixing ...................................................................................... 22
Chapter 4 Maintenance ................................................................................................... 23
4.1 Attentions for Maintenance .............................................................................. 23
4.2 Waste Disposal ................................................................................................ 24

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 Contents

4.3 Storage and Transportation ............................................................................. 24

4.3.1 Storage ................................................................................................. 24
4.3.2 Transportation ....................................................................................... 24
Chapter 5 Troubleshooting ............................................................................................. 25
Appendix A：Instrument Symbols ................................................................................ 28

II
 Copyright and Declaration
Copyright © Paramedical Srl

Declaration:

All contents in this manual were strictly compiled according to related laws and
regulations in Italy, as well as the specific condition of PKLPPC170
coagulation Analyzer, covering all the updated information before printing.
Paramedical Srl is fully responsible for the revision and explanation of the
manual, and reserves the right to renovate the relevant contents without
separate notification. Some of the demonstration pictures are for reference
and subject to real object if any differences.

All the information included is protected by copyright. No part of this document

may be reproduced, stored or transmitted in any form or by any means unless
written authorization by Paramedical Srl.

All instructions must be followed strictly in operation. In no event should

Paramedical Srl be responsible for failures, errors and other liabilities resulting
from user's noncompliance with the procedures and precautions outlined
herein.

Limitation of Liability:

PARAMEDICAL warrants to the original purchaser that this analyzer will be

free from defects in materials and workmanship for a period of one year from
the later of the date of original purchase or installation.

PARAMEDICAL assumes no liability in the following situations even during the

period of warranty.

1. Failure due to abuse the analyzer or neglect the maintenance.

2. Use reagents and accessories other than manufactured or recommended

by PARAMEDICAL.

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 System Description

3. Failure due to operate not under the instructions described in the manual.

4. Replace accessories not specified by PARAMEDICAL, or after maintenance

or repair by a service agent not approved or authorized by PARAMEDICAL.

Paramedical S.r.l.
Via Antonio Amato 24/26
84131 Salerno Italy
Tel. 0039 (089) 385027 fax 0039 (089) 3854479
e-mail assistenza.tecnica@paramedical.it
http://www.paramedical.it

VERSIONE: 01/2013

2
 System Description

Chapter 1System Description

1.1 Overview

PARAMEDICAL Coagulation Analyzer is one kind of semi-auto analyzer with

two or four test channels (PPC120 has two test channels and PPC170 has four
test channels); it adopts the principle of dual-magnetic circuit bead method to
measure the coagulating time of blood components. With the use of
PARAMEDICAL reagent, the analyzer can test PT, APTT, FIB, TT, and blood
coagulation factors. The analyzer guarantees that test results would not be
interfered by hemolysis, chyle, icterus, turbidity, plasma viscosity and other
factors.

This analyzer is mainly used in hospital, research and teaching institutes to

analyze blood coagulation, anticoagulation, fibrinolysis and antifibrinolysis.

The analyzer is for in vitro diagnostic use.

NOTE: the PARAMEDICAL reagent is a must to guarantee the test

precision.

1.2 Electrical Level

According to Italy medical device management classification, this analyzer is

classified to be blood analysis system of Laboratory Medicine instrument
（6840-01.2）, and management category Ⅱ

According to IEC 61010-1:2001, this analyzer is classified to be Pollution

degree 2, overvoltage category Ⅱ.

States of equipment: portable equipment.

1.3 Technical Specification

a) Test principle: dual-magnetic circuit bead method.

3
 System Description

b) Test item: PT, APTT, FIB, TT, Blood Coagulation factor Ⅱ,Ⅴ,Ⅶ,Ⅷ,Ⅸ,
Ⅹ,Ⅺ,Ⅻ, Pro C, Pro S, HEP, LMWH.

c) Test channel: PPC120 has two test channels and PPC170 has four test
channels. The channel deviation is less than 10%.

d) Incubation time and temperature control: incubation time is less than 30

minutes after power on the analyzer when the environmental temperature
is 25℃. After incubation, the temperature of constant temperature device
and incubation cell will keep 37.0℃±1.0℃.

e) Reference range:

Item Reference range Note

PT 10~15 s
INR 0.94~1.3
APTT 23~36s Ellagic acid
FIB 2.00~4.00g/L
TT 8~15s

The reference ranges may be slight different according to the reagent.

f) Repeatability:

The repeatability of analyzer should be complied with table 1.

Table 1 Repeatability

CV
Item
Normal sample Abnormal sample

PT(s) ≤5.0% ≤10.0%

APTT(s) ≤5.0% ≤10.0%

FIB(g/L) ≤10.0% ≤20.0%

TT(s) ≤15.0% ≤20.0%

The abnormal sample means its value is not less than the twice median value

4
 System Description

of normal sample.

g) Accuracy: The relative deviation of FIB is less than 10%.

h) Linearity and related coefficient:

 FIB linearity: 6.5g/L～1.0g/L (650mg/dL～100mg/dL), measurement

range: 13g/L～0.5g/L（1:20,1:5 dilution）

 Related coefficient: γ ≥0.99

i) Display: LCD, English menu, operation information and test result.

j) Printer: print comprehensive report; the internal thermal printer would print
the test result automatically if it’s set to be ON; external stylus printer is
available.

k) Environment specification:

Operation: 15℃～35℃, RH≤80%, 75kPa～106kPa

Storage: -20℃～55℃, RH≤85%, 75kPa～106kPa

l) Control function: functions like self-checking, testing and error judgment

are controlled by microprocessor.

m) COM port: the analyzer can be connected with computer through COM
port.

n) Data capacity: the analyzer can memorize 1000 samples data.

o) Reagent mixing function: the motor drives stirrer to mix the

reagent.(Optional)

p) Power specification: AC100V~240V, 50Hz /60Hz, 45W

q) Net Weight: 5.6Kg

5
 System Description

r) Dimension: 380mm×340mm×130mm

s) Life span: 10 years

1.4 Principle

PPC170 tests the blood coagulation time process with the principle of
dual-magnetic circuit bead method. By simulating blood coagulation condition,
with the chemical reaction of reagent, the analyzer starts the coagulation
waterfall effect to transform fibrinogen into cross linked fibrinogen, and make
the sample solidified. The analyzer measures the solidification time or sample
concentration by testing the movement of magnetic bead. The solidification
time could be exact to 0.005 second. The test results would not be interfered
by hemolysis, chyle, icterus, turbidity, plasma viscosity and other factors.

1.5 Structure

The analyzer appearance is depicted in the following figure.

PKLPPC120 PKLPPC170

6
 System Description

Figure 1

1) Display: displays test result and information.

2) Keyboard: 0~9 keys, decimal point key and function key.

3) Test channel: channel 1 to channel 4 is located on the panel from left to

right. Place the incubated sample on the test channel and user can start
the sample testing.

4) Incubation cell: it is used to incubate the reagent and sample.

5) Internal thermal printer.

6) Pipettor port.

7) Printer port: it is used to connect the external printer.

8) COM: it is used to connect the computer.

9) Analyzer power plug connector.

10) Power switch.

7
 Chapter 2 Installation
2.1 Package Inspection

Unpack and check the shipping container as follows:

a) Carefully unpack the shipping container and take out the analyzer and
accessories.

b) Check the contents according to the packing list for the correct quantity.

c) Please notify the authorized distributor immediately in case of any

damage.

2.2 Installation Requirements

a) Install the analyzer in the room which complies with the operating
environment. It’s recommended to use an air-conditioner to reach the
requirements of temperature and humidity.

b) Install the analyzer on a clean, level and firm surface, which is away from
direct sunlight, intensive magnetic field and moisture environment.

c) Ensure the power outlet is well grounded.

2.3 Printer Installation

a) Press the printer cover to open it (see figure 2).

b) Pull the paper rod and remove the remaining paper if there is any. Mount
the printer paper in it and reset the rod (see figure 3 and figure 4).

c) Make the paper go through the slot of cover, and then close it.

8
 Installation

Figure 2

Figure 3 Figure 4

2.4 Accessories Connection

Connect the other accessories to the analyzer including power cord, pipettor,
external printer and computer through the corresponding ports. Ensure the
power is off when connect these accessories.

9
 Chapter 3 Operation
3.1 Power On

Power on the analyzer and the initialization may take approximate 30 minutes.
The analyzer will be ready to start testing when it accords with the constant
temperature.

NOTE: To ensure the accuracy of test results, please test sample

under the constant temperature.

WARNING: When using reagents, avoid contact with skin and

clothing. In case of that, clean with water and soap immediately. If

contact with eyes, flush with water immediately and seek medical

advice.

WARNING: Potential biohazard. Consider all specimens, surfaces,

or components that contain or have contacted blood, serum as

potentially infectious. Wear gloves, a lab coat, and protective eyewear,

and follow other biosafety practices.

3.2 Test Screen Description

Test screen will display after analyzer self-checking, which could be divided
into four areas like figure 5.

Figure 5

10
 Operation

a) In this area, it shows the number of next sample and incubation cell
temperature. The temperature may be different from the temperature of
incubated reagent or sample. It will display “T: H” on the screen if the
temperature is higher than 39℃.

b) Result area: this figure showing test screen, there are 2 channels: CH1 and
CH2. Following the channel number, test item, sample No., time and result
will be displayed.

“*” means the selected test channel.

“!” means the testing channel.

Press CH key to change test channel and the selected channel will be
displayed with “*”.

Press 2 or 8 on the keyboard to change test item.

Press Start key or press pipettor switch, the analyzer begins to test.

c) PTAVE indicates the PT mean value of normal sample. Each lab should set
its own PTEVE and mean time.

ISI coefficient should be corresponding with ISI value given by reagent.

d) In this area, current time and incubation time will be displayed.

3.3 Keyboard

The following figure depicts the keyboard.

8
8

Figure 6

Figure 6

11
 Operation

1) Menu key: press this key to enter the main menu, or give up the current
operation and exit.

2) 0~9 numeric keys: press these keys to input figures, such as: incubation
time, concentration, date, etc. Press 2 or 8 to change the test item. Refer
to chapter 3.4.4 for more query functions.

3) CH (channel) key: press CH key to select the test channel.

4) IT (incubation time) key: press this key to set the incubation time.

5) IS (incubation start) key: press this key to start the incubation, and the
analyzer begins to count down the incubation time. Audible beeps
indicates that the incubation processing is completed, press this key again
to stop the beeps.

6) OK key: press this key to confirm the operation.

7) Start key: press this key to start test.

8) Decimal point key: press this key to input decimal point when input figures;
from test screen and query screen, press this key to paper throw one row.

3.4 Main Menu

Press Menu key, the main menu screen like following figure will be displayed.

Figure 7

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 Operation

3.4.1 Set

From main menu screen, press 1 to enter the SET screen, on which the low
limit and high limit values of test items could be set. Press numeric keys to
input desired figures; Press OK to confirm the input. Press Menu key to give up
the input and back to the previous menu.

NOTE: The date must be input completely, including decimal point

and after figures.

3.4.2 Time

From main menu screen, press 2 to enter the DATE screen, on which the
current date and time could be set. Press numeric keys to input desired figures;
Press OK to confirm the input. Press Menu key to give up the input and back to
the previous menu.

3.4.3 No.

From main menu screen, press 3 to enter NO. screen, on which sample
number could be set. Press numeric keys to input desired figures; Press OK to
confirm. Press Menu key to give up the input and back to previous menu.

3.4.4 Query

3.4.4.1 Query Menu

Press 4 to enter into query menu (figure 8)

1 View
2 Contrl Test OFF
Contrl View
3 PT
4 APTT
5 TT
6 FIB

Figure 8

13
 Operation

1: Press 1 to access the normal test results.

2: Press 2, and set the QC test. Press 2 to turn on or off the QC test. If in the
mode of QC test, “QC Test” will be displayed in lower right corner of the
interface. Test data will be used for QC management. The procedure of QC
test is similar to normal test, please refer to corresponding test procedure; if
QC test is off, “QC Test” will be not displayed. Data is for normal test. Analyzer
will enter Normal Data Test on each boot.

3: QC Manage Menu. Press 3, 4, 5, 6, operator could view the QC chart and

QC test data of PT、APTT、TT、FIB items respectively. Press “OK” to print QC
chart. Press Menu key to give up the input and back to the previous menu.

3.4.4.2 Normal Test Data Query

Press 1 to enter Query Menu (Figure 7).

Press 2 or 8 to review the query result downward or upward.
Press 3 or 9 to review 10 results downward or upward.
Press 1 to print the current screen data.
Press 0 to print 10 continuous results forward.
Press OK to print all the results of current test. It means to print the results of
the new test after using this function to print or since starting up. Test data
could only be printed once by using this function. The data have been printed
out could not be printed again by press OK but by press 1or 0.
Press Menu key to give up the input and back to the previous menu.

No: 000010
2009-09-09 09:09:09
PT: 12.2 R: 0.86 INR: 0.86
APTT 28.2
TT 12.0
FIB 2.50 (g/L) 12.2 （S）

2:Dn 8:Up 3:PgDn 9:PgUp

1:Print 1 0:Print 10
Press ok to test print

Figure 7

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 Operation

3.4.5 Calibration

a) FIB concentration calibration

Before FIB test, the concentration calibration must be performed using the
valuing plasm or calibrated normal plasm. Firstly, dilute the plasm to four
different concentrations; secondly, test each concentration at least 10 times,
and then calculate the mean values of these four concentrations. Thirdly, input
the test values as the following steps.

 From main menu screen, press 5 to enter the CALIBRATION screen

with the password of 000000.

 Press numeric key to select FIB calibration, the last lot number will be
displayed and input the new calibration lot number at the cursor
position, press OK to save it.

 The last calibration data will be displayed on the screen, and input the
new calibration data at the cursor position. Press OK to confirm the
input. Press Menu key to give up the input and back to the previous
menu.

b) Blood coagulation factor calibration

 From main menu screen, press 5 to enter the CALIBRATION screen

with the password of 000000.

 Press numeric key to select factor calibration, ten factors of

Ⅱ,Ⅴ,Ⅶ,Ⅷ,ⅨⅩ,Ⅺ,Ⅻ, HEP, LMWH will be displayed. Select one factor,
THE last lot number will be displayed and input the new calibration lot
number at the cursor position, press OK to save it.

 The last calibration data will be displayed on the screen, and input the
new calibration data at the cursor position. Press OK to confirm the
input. Press Menu key to give up the input and back to the previous
menu.

15
 Operation

From the calibration screen, press 1 to set the APTT-R and TT-R to be ON or
OFF. If it’s set to be ON, APTT and TT should be set from SET screen, and
their test results will be displayed and print when output.

3.4.6 Max Test Time

Press 6 to set the max test time. Max test time indicates that when the testing
time reaches the max value, the analyzer will stop timing no matter whether
the sample coagulated or not. Max test time could be set by user between 60
to 999 seconds.

3.4.7 FIB Unit

Press 7 to alternate the FIB unit between “g/L” and “mg/dL”.

3.4.8 Print and Default

Press 8 to enter Print and Default screen, from which set the internal printer to
be ON or OFF, and reset the analyzer to be factory default. (Figure 8)

Press 0 to reset the default value, it includes normal range of every item,
reference time of PT、APTT and TT, scaling parameter of FIB.
Press 1 to set the internal printer to be ON or OFF.
Press 2 to print output Italian project name in Italian mode.
Press 3 to set the test print to be ON or OFF. If test print is on, the analyzer
could print the test result while testing; if test print is off, the test result would
not be printed out while testing.
0 Default
1 Printer ON
2 Print English
3 Test print ON (OFF)

Press Data to enter

corresponding option
Press Menu to return

Figure 8

16
 Operation

3.4.9 Technical Support

Press 9 to enter the technical support screen, and user can view the serial port
setup and manufacturer information.

3.5 Test Item

Please carefully read this chapter before testing, and ensure all parts needed
are available.

a) PPC170/175Coagulation Analyzer

b) Reagent

c) Pipettor

d) Bead adding device

e) Sample cup (disposable cup)

f) Sample

g) Magnetic bead

Set the test items accordingly before test, and refer to the reagent instruction
for more information about sample handling and reagents making and
incubating.

3.5.1 Quality Control

Analyzer performs QC test and establishes reference fits for its own laboratory.

3.5.1.1 Quality Control

Necessary quality control to the measurement system is required to insure the

accuracy for counting and analyzing, as well as duly eliminating the system

17
 Operation

error. So it’s recommended to perform quality control with normal and

abnormal control every day. Each lab should establish its own reference
values.

User can set the reference value based on various normal human blood.

3.5.1.2 Quality Control Management

Query Menu (Figure 6). Press 3, 4, 5, 6 to enter QC chart interface of PT, APTT,
TT, FIB items. QC chart interface will list all QC data of current item (Figure 9),
it includes Mean PT-S, D-value SD, times of QC test——n: xx (xx refers the
number of QC data). The data in upper right corner is the QC data which could
only save up to 20. If more than 20, the latest data will replace the oldest.

Press OK to print current QC chart and related data, it includes Mean (Item:
average data), SD:XX, times of test n:xx.

Press Menu to return.

3.5.1.3 Quality Control Test

Set QC test follow Chapter 3.4.4.1 Query Menu. The procedure of the test is
similar to normal test. Refer to chapter 3.5.2 to 3.5.6 for details.

Figure 9 Quality Control Query Interface

18
 Operation

3.5.2 PT Test

Perform PT test according to the following procedures:

a) Put a magnetic bead in the sample cup and inject 50μL sample by pipettor.

b) Incubate the sample.

c) After incubation, add 100μL incubated PT reagent, and press Start key or
pipettor switch to start the test.

d) The counter and magnetic mix device will stop when fibrin polymerization
and coagulum appear. The test is finished and the results will be displayed
on the screen.

3.5.3 APTT Test

Perform APTT test according to the following procedures:

a) Put a magnetic bead in the sample cup and inject 50μL sample by pipettor.

b) Inject 50μL APTT reagent into sample cup.

c) Incubate the sample.

d) After incubation, inject 50μL incubated CaCl 2 reagent and press Start key
or pipettor switch to start the test.

e) The counter and magnetic mix device will stop when fibrin polymerization
and coagulum appear. The test is finished and the results will be displayed
on the screen.

3.5.4 TT Test

Perform TT test according to the following procedures:

a) Put a magnetic bead in the sample cup and inject 100μL sample.

19
 Operation

b) Incubate the sample.

c) After incubation, inject 100μL TT reagent and press Start key or pipettor
switch to start the test.

d) The counter and magnetic mix device will stop when fibrin polymerization
and coagulum present. The test is finished and the results will be displayed
on the screen.

3.5.5 FIB Test

Perform FIB test according to the following procedures:

a) Put a magnetic bead in the sample cup and inject 100μL diluted sample.

b) Incubate the sample.

c) Put the cup on the test channel after incubation. Set the test channel
correctly, then inject 50μL FIB reagent into cup. Press Start key or pipettor
switch to start the test.

d) The counter and magnetic mix device will stop when fibrin polymerization
and coagulum appear. The test is finished and the results will be displayed
on the screen.

NOTE: “Clauss” method is taken to test FIB value. FIB calibration

must be done in the initial use. When changed the reagent lot, the normal
and abnormal quality control must be done. If the QC results are
unconformity, please make the FIB calibration.

3.5.6 Blood Coagulation Factor Test

For testing blood coagulation factors such as Ⅱ, Ⅴ, Ⅶ, Ⅷ, Ⅸ, Ⅹ, Ⅺ, Ⅻ, ProC,

ProS, HEP and LMWH, the concentration curve calibration of these test items
must be done firstly. Press 2 or 8 to select the desired test item, then select the

20
 Operation

corresponding reagent and refer to its instruction to calibrate the concentration

curve. Chapter 3.4.5 offers more information concerning calibration. After
calibration, perform blood coagulation factor test using proper reagent in
accordance with its instruction.

3.5.7 Result Report

The test result will be displayed after finishing a sample test, and print the
result automatically if the printer is ON. If the test results are abnormal, test the
sample again to ensure the results are correct. If there is no magnetic bead in
the sample cup or the bead is not driven, message of “No bead” will be
displayed on the screen.

3.5.8 Concentration Curve Calibration

Refer to chapter 3.4.5 for details.

3.5.9 Sample Collection and Storage

a) Sample collection: collect venous blood into laboratory test tube or vial
which contains 1/10 volume of 0.109mol/l natrium citricum anticoagulant
(i.e. one volume of venous blood and nine volumes of anticoagulant are
mixed). After the sample mixed completely, centrifuge the sample for 15
minutes at 3000rpm. Collect the plasma locating on the upper layer after
centrifugation.

b) Sample storage: the sample shelf life is various depending on the storage
temperature.

 The sample will be stable for 30 days when stored at－80℃.

 The sample will be stable for 14 days when stored at－20℃.

 The sample will be stable for 6 hours when stored at 2℃~ 8℃.

 The sample will be stable for 2 hours when stored at 22℃~ 24℃.

21
 Operation

3.5.10 Reagent Mixing

Place the reagent tube which needs to be mixed in the position with . Put
the stirrer into the reagent tube, switch the mix button to “ | ” and turn on the
stirrer motor. Switch the mix button to “ o ” and turn off the stirrer motor when
finished.

NOTE:

a) Please refer to the reagent instruction for details concerning reagent

dosage, defreeze, re-dissolve, making and incubation.

b) Take the factors influencing blood coagulation into consideration,

please perform testing as soon as possible after sample collection.

22
 Chapter 4 Maintenance
This analyzer is one kind of precise instrument which requires proper
maintenance to keep optimum performance. Any accessories damaged or
improper operation will affect the analyzer function. If any malfunction occurs,
it should be maintained by authorized engineer or contact PARAMEDICAL
Service Center.

4.1 Attentions for Maintenance

a) Please carefully read this manual before operating the analyzer.

b) Install the analyzer on a clean, level and firm surface, which is away from
direct sunlight, intensive magnetic field and moisture environment. The
preceding conditions may cause analyzer malfunction.

c) Please use the proper reagents offered by PARAMEDICAL to ensure the

test accuracy.

d) Power supply should meet specific requirements.

e) The analyzer must be well grounded.

f) If the analyzer is not used for a long term, place a plastic or cloth cover on
it for protection. Before re-using the analyzer, perform normal and
abnormal reference blood simultaneously, and perform quality control with
control material to monitor the reference value. These operations could
eliminate the interference caused by analyzer components, reagents and
abnormal operation.

g) DO NOT disassemble the analyzer by yourself.

h) Keep the analyzer clean and dust-free. Clean the analyzer appearance
with toweling or other absorbent material moistened by mild detergent.
Wipe the display only with ethyl alcohol, it’s forbidden to use water, ketone
and aromatic detergent. Any components of the analyzer cannot be

23
 Maintenance

contaminated by grease, silica gel or lubricant.

i) Keep the magnetic beads away from electromagnet to avoid magnetization.

In case of that, DO NOT use the beads.

j) If any malfunction occurs, troubleshoot according to the chapter 5 for

details. If the problems are not solved, please contact PARAMEDICAL
Service Center.

4.2 Waste Disposal

Please handle and dispose of the waste in accordance with local, state and
federal regulation.

4.3 Storage and Transportation

4.3.1 Storage

Store the analyzer in the environmental condition of ventilation, corrosive

gas-free, harmful gas-free, and in accordance with following specifications:

a) Environmental temperature: -20℃～55℃

b) Relative Humidity: ≤85%RH

c) Barometric pressure: 75kPa～106kPa

4.3.2 Transportation

Transport the analyzer protecting from impact, keep dry and away from direct
sunlight.

24
 Chapter 5 Troubleshooting
This chapter gives instructions for troubleshooting. If a problem is detected, the
display will indicate the message. The following table guides users to judge
fault condition and take corresponding corrective action. If the malfunction still
occurs, please contact PARAMEDICAL Service Center. If the malfunction
caused by reagents, please read reagent instruction carefully for problem
solution. The troubleshooting personnel should be trained or authorized by
PARAMEDICAL.

WARNING: Electrical Hazard.

Malfunction Probable Cause Corrective Action

Nothing a) Power off. a) Check the fuse in analyzer.

displayed on Ensure the analyzer has
b) Circuit malfunction.
the screen. connected to the power
supply.

b) If the malfunction caused

by circuit problem, please
contact PARAMEDICAL
Service Center.

Self-checking Analyzer internal memory or IC a) Shutdown the analyzer and

error error. check the voltage of power
supply. Re-start the
analyzer after 30 seconds.

b) Analyzer inside RAM/ROM

is broken, please contact
PARAMEDICAL Service
Center.

No bead a) The bead is not placed in a) Ensure the bead placed

25
 Troubleshooting

Malfunction Probable Cause Corrective Action

test cup. normally.

b) Reagent is insufficient. b) Ensure there is sufficient

reagent.
c) Other problems.
c) Check the voltage of power
supply, if the problem still
occurs, please contact
PARAMEDICAL Service
Center.

Test results a) The printer is set to be OFF. a) Set the printer to be ON.
cannot be
b) There is no print paper. b) Install new print paper.
printed by
internal c) Printer cable is loose. c) Check the printer cable.

printer. d) Printer problem. d) Please contact PARAME

DICAL Service Center.

Key-press a) Key-press is broken. a) Shutdown the analyzer

problem and re-start the analyzer
b) Circuit problem.
after 30 seconds.

b) Please contact PARAME

DICAL Service Center.

T:H (the a) Incubation cell temperature a) Ensure the environment

temperature is high. temperature is in the
is high) acceptable range.
b) Sensor is disabling.
b) Please contact PARAME
c) Circuit problem.
DICAL Service Center.

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 Troubleshooting

Malfunction Probable Cause Corrective Action

Mixing is a) Switch contact is poor a) Check the switch.

disabling.
b) Stirrer motor is disabling b) Check the voltage of stirrer

motor.

If the following situations happen, please contact PARAMEDICAL Service

Center for problem solution:

a) The malfunction cannot be solved according to the preceding table.

b) Accessories or components are damaged in operation.

c) Main part of the analyzer is damaged.

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Appendix A：Instrument Symbols

Caution Biohazard

Off (Supply) On (Supply)

Protect from heat

In vitro diagnostic
and radioactive
medical device
sources

Manufacturer Serial number

Separate
Authorized
collection for
representative in the
electrical and
European
electronic
Community
equipment

European
Equipotentiality
Community

Reagent Mixing

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